Impact of Preoperative 3D Printed Stoma Placement on the Quality of Life of Ostomy Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-29

Study Completion Date

2023-09-30

Brief Summary

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The making of an ostomy in patients is experienced as traumatic. The stoma changes body image, self-esteem and is responsible for increased anxiety. These changes affect the quality of life of patients. To reduce the negative impact of the stoma, patients are seen in preoperative consultation by the stoma nurses. This consultation allows to show the patients the appearance of a stoma (through a photograph), the equipment used and how it works.

In 2016, McKenna et al. showed the interest of marking (with felt pen) the ostomy site on the abdomen in preoperative. In this study, patients with preoperative marking had a higher post-operative quality of life score than patients without marking (p=0.03).

Quality of life was assessed using the STOMA-QOL score. This quality of life score is specific for ostomy patients. It assesses 4 dimensions: sleep, intimate relationships, relationships with family and close friends, relationships with people other than family and close friends. This questionnaire includes 20 questions and has been validated in 5 languages including French.

The aim of this pilot study is to evaluate the post-operative quality of life of ostomy patients who have benefited from a preoperative therapeutic education session with the placement of the 3D printed ostomy button versus felt-tip marking, during the 15 days prior to the operation.

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Detailed Description

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Conditions

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Ostomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Felt-tip marking

Group Type ACTIVE_COMPARATOR

Felt-tip marking

Intervention Type OTHER

Marking the location of the future stoma with a felt pen

Felt-tip marking + 3D printed ostomy button

Group Type EXPERIMENTAL

Felt-tip marking + 3D printed ostomy button

Intervention Type OTHER

Marking the location of the future stoma with a felt pen + 3D printed ostomy button placed on the future stoma location

Interventions

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Felt-tip marking

Marking the location of the future stoma with a felt pen

Intervention Type OTHER

Felt-tip marking + 3D printed ostomy button

Marking the location of the future stoma with a felt pen + 3D printed ostomy button placed on the future stoma location

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patient ≥ 18 years old,
* First ileostomy with indication for temporary stoma placement,
* Patient with scheduled surgery,
* Patient who has the capacity to understand the protocol and has given consent to participate in the research,
* Patient with social security coverage.

Exclusion Criteria

* Patient \< 18 years old,
* Patient with an indication for placement of a permanent stoma,
* Emergency surgery patient,
* Patient who are pregnant, breastfeeding, or who have the potential to become pregnant without effective contraception,
* Patient under guardianship, curators or legal protection,
* Patient participating in another interventional clinical research protocol involving a drug or medical device.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No